Quality & Regulatory Affairs Analyst

Posting Details

Position Information -------------------

Posting Number: S06585P Position Title: Quality & Regulatory Affairs Analyst Department: TMAC Location: Arlington Position Status: Full-time Work Schedule: Monday-Friday, 8:00am-5:00pm. Hybrid position - office space available but most work will be conducted on-site with customers at their facilities. Regular travel to various client sites which may be located regionally or across the state of Texas. Some interstate travel may be required as customer demand and grant obligations require.

Salary -------

Salary is commensurate based on qualifications and relevant experience. Pay Basis: Monthly

Job Summary ------------

The Quality & Regulatory Affairs Analyst Research Engineering Scientist Assoc V will deliver hands-on quality management and regulatory affairs solutions to a wide range of businesses including manufacturing, distribution, logistics, construction, healthcare, and government. Contribute to TMACs wide array of services that accelerate profitable growth by developing and improving profits, products, processes, technologies, and people.

Essential Duties and Responsibilities --------------------------------------

### Quality Management Systems

• Assist in the development, implementation, and maintenance of Quality Management Systems (QMS) for TMAC customers in accordance with various standards, including but not limited to:
• ISO 9001
• AS9100
• AS9110
• ISO 13485
• IATF 16949
• Conduct internal audits to ensure compliance with QMS and regulatory requirements.
• Develop and improve quality procedures, work instructions, and policies to maintain compliance and documentation requirements.

### Training & Education

• Train and educate Customers and TMAC Personnel, including TMAC regions across the state, on quality management systems applicable standards, regulatory requirements, and best practices.
• Educate internal and external teams on new regulations, standards, and updates in impacted industries.
• Attend training and professional development courses to stay informed of new standards, policies, procedures, and practices.
• Present technical sessions at industry conferences and tradeshows to represent TMAC.

### Audit Preparation & Support

• Prepare for and support external audits and inspections for TMAC customers.
• Address and respond to audit findings, non-conformities, and observations.
• Recommend improvements and solutions.
• Design, prepare, and conduct internal audits for TMAC customers.
• Report on audit findings and assist with solutions.

### Environmental Systems

• Integrate QMS standards with Environmental Management Systems (ISO 14001) and Safety Management Systems (ISO 45001) as required by TMAC customers for compliance.

### Project Management

• Source and follow up on leads, develop proposals, and follow up with potential customers throughout the sales process.
• Provide management consulting, operational excellence, and product/process engineering solutions to accelerate the profitable growth of TMAC customers.
• Manage multiple overlapping customer projects with strong attention to detail, excellent organizational, and interpersonal skills, and maintain customer sponsor satisfaction.

Minimum Qualifications --------------------

• Bachelors degree in STEM or related field.
• Ten (10) years industry experience in manufacturing or an equivalent mix of education and relevant experience in similar role.
• Five (5) years of experience conducting internal audits ISO 9001, AS9100, AS9110, ISO 13485, IATF 16949.
• Demonstrated experience in process control tools, Statistical Process Control, Design of Experiments, Measurement System Analysis, etc.

Preferred Qualifications ----------------------

• Masters degree in a STEM or related field.
• AS9100 or ISO 13485 Certified Lead Auditor.
• Experience designing and implementing quality management systems in industry at least 10 implementations.
• Strong foundation in manufacturing processes and process improvement methodologies.
• Experience in Aerospace Defense or Medical Device Manufacturing industries.
• Knowledge, skills, and abilities:
• Verbal and written communication skills.
• Ability to work with all levels of personnel, C-suite to shop floor.
• In-depth understanding of regulatory requirements and standards.
• Knowledge of QMS principles and practices, including auditing and compliance.
• Proficiency in preparing and reviewing regulatory documents, technical files, and quality documentation.
• Analytical and problem-solving abilities to assess compliance issues and develop effective solutions.
• Excellent written and verbal communication skills for preparing documentation, reports, and conducting training sessions, C-suite to shop floor.
• Ability to manage multiple projects, prioritize tasks, and meet deadlines.
• Commitment to staying updated with regulatory changes, industry trends, and new technologies.
• High attention to detail to ensure accuracy and completeness in regulatory submissions and quality documentation.
• Sense of ethics and understanding of legal implications in regulatory affairs and quality management.

Other Requirements ------------------

• Overtime may be needed to fulfill customer requirements.
• Workplace and Eligibility Conditions: May be exposed to industrial settings or manufacturing plants, some conditions may be hazardous.
• Benefits: Eligible
• Benefits at UTA: We are proud to offer a comprehensive benefits package to all our employees at the University. https://www.uta.edu/hremployee-benefits
• To help you understand the full value of these benefits, we have created a tool that calculates the total worth of your compensation package. This tool takes into account all of the benefits that you are eligible for, including health insurance, retirement plans, and paid time off. To access this tool and learn more about the total value of your benefits, please click on the following link: https://resources.uta.edu/hrservices/records/compensation-tools.php
• CBC Requirement: It is the policy of The University of Texas at Arlington to conduct a criminal background check on any applicant who is under final consideration for employment with the University. This position may have access to critical infrastructure as defined by Section 113.0012 of the Texas Business and Commerce Code. If so, to be hired for and continue to be employed in this position, you must maintain the security or integrity of the infrastructure as set forth in Texas Executive Order GA-48. By assuming this position and if you have access to critical infrastructure, you authorize the University to conduct routine background checks.
• EEO Statement: It is the policy of The University of Texas at Arlington, UTA, or The University to provide an educational and working environment that provides equal opportunity to all members of the University community. In accordance with federal and state law, the University prohibits unlawful discrimination, including harassment, on the basis of race, color, national origin, religion, age, sex, sexual orientation, pregnancy, disability, genetic information, and/or veteran status. The University also prohibits discrimination on the basis of gender identity and gender expression. Retaliation against persons who oppose a discriminatory practice, file a charge of discrimination, or testify for assist in or participate in an investigative proceeding relating to discrimination is prohibited. Constitutionally-protected expression will not be considered discrimination or harassment under this policy. It is the responsibility of all departments, employees, and students to ensure the Universitys compliance with this policy.
• University Information: The University of Texas at Arlington, UTA, is located in the heart of the Dallas-Fort Worth-Arlington metroplex, a vibrant and diverse metropolitan area that is home to over 7 million people, one of the fastest-growing tech economies in the United States, and a wide array of arts, entertainment, and cultural activities. As a comprehensive teaching, research, and public service institution, UTA is dedicated to the advancement of knowledge through scholarship and creative work. With an enrollment of more than 42,000 students, UTA is the second largest in the University of Texas System. As a result of its combination of rigorous academics and innovative research, UTA is designated as a Carnegie R-1 Very High Research Activity institution and nationally recognized for its commitment to student success and service. It ranks No. 5 in Military Times Best for Vets Colleges and is the top university in North Texas for its graduates salaries, The Wall Street Journal. UTA is designated as both a Hispanic-Serving Institution and an Asian American and Native American Pacific Islander-Serving Institution and is No. 6 for undergraduate ethnic diversity in the United States, U.S. News & World Report 2023. With a global alumni network of approximately 280,000, including leaders at many of the 24 Fortune 500 companies headquartered in North Texas, UTA contributes an estimated $29 billion annually to the Texas economy. UTA is expanding its regional footprint by building a regional campus called UTA West in Parker County on the far west side of Fort Worth. It is scheduled to open in fall 2028. This initiative aligns with the universitys strategic growth and commitment to serving the broader community. Furthermore, UTA has launched the RISE 100 initiative, aiming to recruit 100 new tenure-system faculty to strengthen its research enterprise and leadership in key academic areas. Learn more at https://www.uta.edu/administration/president/strategic-plan/RISE100.
• ADA Accommodations: The University of Texas at Arlington is committed to providing reasonable accommodation to individuals with disabilities. If you require reasonable accommodation in completing this application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to 817-272-5554 or email ADA Docs@uta.edu.